This part of this European Standard specifies general safety requirements relating to the materials, construction, packaging and labelling of soothers. It includes also requirements relating to the instructions for use. This European Standard is applicable to products that resemble or function as a soother unless they are being marketed as medical devices. This European Standard does not apply to products designed for specialist medical applications, e. g., those relating to Pierre-Robin Syndrome or premature babies. These special cases are described in an informative annex (see Annex A). NOTE It is recommended that soothers excluded from the scope of this European Standard should meet those requirements that can be applied. The standard is not applicable to feeding teats.